REWRITE-CAD Protocol: Risk Evaluation With AI-CPA to Reduce Progression and Improve Lifetime Care for Patients With Known Coronary Artery Disease

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHeartFlow, Inc.

About this trial

REWRITE-CAD is a prospective, randomized, multi-center trial assessing the management of asymptomatic participants with a history of PCI or MI who will undergo a blinded CCTA and be randomly assigned to either the test arm in which participants receive the unblinded results of Heartflow AI-CPA or the usual care arm in which participants are blinded to the AI-CPA results.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

History of PCI (1 year - 5 years prior to Day 0) and/or history of MI (Type I or II) (1 year - 5 years prior to Day 0)

Patients who do not exhibit symptoms suggestive of CAD

No other clinical CCTA subsequent to MI/PCI but prior to screening

eGFR >45 mL/min per most recent measurement within 90 days

Disqualifiers

Symptoms suggestive of CAD (e.g. stable angina or dyspnea on exertion)

On PCSK9i and/or inclisiran at baseline

Reduced left ventricular ejection fraction (LVEF) <35%, if known

Prior coronary artery bypass graft (CABG)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Heartflow Analysis

    Device

    REWRITE-CAD will provide AI-CPA results

Treatment groups

350 Participants
are divided into 2 treatment groups
Group A: Usual Care ArmNo intervention 0 interventions
Group B: Unblinded AI-CPA Test ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)

Time frame
Enrollment to 90 days

Secondary outcomes

1

Percentage of participants who initiate or intensify lipid-lowering therapy (LLT)

Time frame
Enrollment through end of study at 21 months
2

Percentage of participants who initiate or intensify cardiovascular disease prevention medication therapy

Time frame
Enrollment through end of study at 21 months
3

Time to intensification of LLT

Time frame
Enrollment through end of study at 21 months
4

% Undergoing lipid testing

Time frame
Enrollment through end of study at 21 months

Other outcomes

Sponsors and contacts

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HeartFlow, Inc.

Lead sponsor

Avania

Collaborator

This trial is not recruiting at the moment. You can still explore other options: